This document discusses safety considerations regarding probiotics. It notes that safety assessments must take into account the microbe used, administration method, exposure level, and user health status. While few adverse events have been reported, they primarily occur in individuals with underlying conditions. Further research is needed on probiotic use in at-risk populations like immunocompromised individuals. International regulatory frameworks are needed to address probiotic efficacy, safety, labeling, and claims.

1. SAFETY REGARDING
PROBIOTICS

2. • Microbes used as probiotics are derived from
different genera and species and have been
studied for a variety of health and disease
endpoints.
• Currently, both yeast (Saccharomyces cerevisiae)
and bacteria are used as probiotics, including
lactic acid bacteria (LAB; such as species of
Lactobacillus, Streptococcus and Enterococcus),
Bifidobacterium, Propionibacterium, Bacillus and
Escherichia coli. They may be naturally occurring
microbes (as is the case for all used in food), or
microbes that have been genetically altered for a
specific effect.

3. Assessment of safety must take into account :
• Nature of the microbe being used
• method of administration
• level of exposure
• health status of users

4. • An increasing number of well-controlled
human studies that have tracked adverse
incidents have been reported.
• Furthermore, as usage of probiotics has
expanded and methods to track specific
strains have improved, reports of
infections and other adverse incidents
traced to specific probiotics have
surfaced.

5. • Documented correlations between adverse
events and probiotic consumption are few
considering their widespread use.
• With few exceptions, adverse events have
been reported primarily in patients with
underlying medical conditions .
• Since microbes used as probiotics are non-
pathogenic, it is difficult to identify inherent
strain properties that may be related to
health risks.

6. • For instance, the risk of Lactobacillus infection
is estimated at about one case per 10 million
people over a century of probiotic
consumption in France.
• Moreover, the risk of lactobacillemia was
considered as ‘unequivocally negligible.
• Further investigation is warranted for
probiotic use in at-risk human populations
such as severely immunocompromised
subjects, neonates or hospitalized patients

7. • The regulatory status of probiotics as a
component in food has to be established on an
international level.
• A regulatory framework should be established
to better address probiotic issues, including
efficacy, safety, labeling, fraud, and claims.
• Probiotic products should be made more widely
available, especially for relief work and to
populations at high risk of morbidity and
mortality.
• Foods that could be regarded as functional
foods are subject to regulations drawn up for
other food groups

8. • The US Food and Drug Administration (FDA) defined four food
categories:
• conventional foods, constituting the largest category and including
articles of food and drink that do not fall into the other three categories
such as foods for special dietary use; medical foods; and dietary
supplements.
• Government regulations regarding safety assessment differ among
countries, and the status of probiotics as a component in food is
currently not established on an international basis
• For the most part, probiotics come under food and dietary
supplements because most are delivered by mouth as foods and, as
such, are allowed to make only general health claims.
• The factors that must be addressed in the evaluation of safety of
probiotics include pathogenicity, infectivity, and virulence factors
comprising toxicity, metabolic activity, and the intrinsic properties of
the microorganisms.

9. • It was recognized that there is a need to accurately
enumerate the probiotic bacteria in food products to include
them on a label and that proper manufacture and handling
procedures be employed to ensure the maintenance of
viability and probiotic activity through processing, handling,
and storage of probiotic foods, including powdered milk
products.
• Good evidence exists that specific strains of probiotics are
safe for human use and able to confer some health benefits
on the host,
• but such benefits cannot be extrapolated to other strains
without experimentation.
• As there has been an increased influx of probiotic products
in the Indian market during the last decade, therefore an
initiative was taken by the Indian Council of Medical
Research ( ICMR) and Department of Biotechnology,
Government of India ( DBT), to formulate guidelines for the

10. Future prospects: toward genetically
modified designer probiotics
• Genetic manipulation offers the potential to
enhance the
existing probiotic properties of an organism or
to load an organism with probiotic properties .
• Elucidation of mechanisms of activity of a
probiotic could enable the manipulation of
organisms to create specific and targeted
probiotics.
• consumer acceptance to GMO probiotic foods
are unlikely to be accepted in the near future

11. • A set of parameters required for a
product/strain to be termed as ‘probiotic’.
These include
• identification of the strain,
• in vitro screening for probiotic characteristics,
• in vivo animal and human studies
• to establish efficacy,
• requirements for labeling of the probiotic
products with strain specification, viable
numbers at the end of shelf-life, storage
conditions, etc.,
• so as to help the consumers to safeguard their
awareness.

12. Validation of health claims
• To validate or substantiate a health-related claim, the
proposed relationship between the product and the health-
related end point should be identified, and appropriate
measurements of both should be indicated
• The interests of patients and consumer involvement are
becoming integral part of clinical development and should be
taken into consideration.
• For regulatory purposes, health-related claims require sound
evidence from all available sources.
• Positive evidence should not be outweighed by negative
evidence, and sufficient evidence based on human
experience should be available to support the safety and
efficacy, including pre- and post marketing experience.